NCT05355194

Brief Summary

This study aims to determine the effects of kinesiotaping with \& without pelvic tilts on pain \& menstrual distress in females with dysmenorrhea. This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

April 21, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

dysmenorrheaActive stretchingKinesiotape

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is an outcome measure that is unidimensional measure of pain intensity in adults. It is segmented numeric version of Visual Analogue Scale (VAS) in which respondents select a whole number from 0-10 that best reflects the intensity of their pain.

    up to 12 weeks

  • WaLLID Scale:

    Proposed in 2018 by Teherán et al., working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD; based on pain score and use of painkillers) is a combination of multiple scales, which has been developed with the goal of measuring the severity of dysmenorrhea and predicting the resultant activity limitation.

    up to 12 weeks

  • Menstrual Distress Questionnaire:

    Menstrual Distress Questionnaire is a tool developed by Moss that measures the severity and symptoms associated with menstruation. Kim designed a revised version of Menstrual Distress Questionnaire to determine the type of discomfort during menstruation wit 35 questions.

    up to 12 weeks

Study Arms (2)

Group A: Kinesiotaping with pelvic tilts

EXPERIMENTAL

Kinesiotape will be applied to patients. In addition, patients will be instructed to perform pelvic tilts.

Other: KinesiotapeOther: Pelvic Tilts

Group B: Kinesiotaping without pelvic tilts

ACTIVE COMPARATOR

Kinesiotape will be applied to patients.

Other: Kinesiotape

Interventions

Patients will be instructed to inhale while taping the application. The tape will be applied in a vertical direction from just below the navel to the pubic region, another tape will be applied over the initial tape in the horizontal direction with minimal stretch. Another tape will be applied over the lumbosacral region making a V shape. The arms of V shall lie over the lumbar region while the base shall rest over the caudal region. Taping will be maintained for at least 48 hours. The interventions shall be applied for two consecutive menstrual cycles.

Group A: Kinesiotaping with pelvic tiltsGroup B: Kinesiotaping without pelvic tilts

Patients will be asked to lie in a supine position with legs bent and toes facing forward. Afterward, they will be instructed to pull their belly inwards while pushing pelvis towards the ceiling and keep hip muscles tightened. This position will be maintained for 5 seconds with 3 sets of 20 repetitions. Pelvic tilts must be performed throughout the menstrual cycle.

Group A: Kinesiotaping with pelvic tilts

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30 years
  • Nulliparous
  • Regular menstrual cycles
  • Primary dysmenorrhea (diagnosed via WaLLID tool)

You may not qualify if:

  • Allergic to kinesiotape
  • Skin disorders
  • Uterine fibroids
  • Endometriosis
  • Polycystic Ovarian Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sialkot

Sialkot, Punjab Province, 54700, Pakistan

Location

Related Publications (11)

  • Reddish S. Dysmenorrhoea. Aust Fam Physician. 2006 Nov;35(11):842-4, 846-9.

    PMID: 17099800BACKGROUND
  • Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.

    PMID: 24284871BACKGROUND
  • Johnston L. Menstrual pain (dysmenorrhoea). Professional Nursing Today. 2014;18(1):13-4.

    BACKGROUND
  • Smith R, Kaunitz A. Primary dysmenorrhea in adult women: clinical features and diagnosis. Alphen aan den Rijn: Wolters Kluwer. 2015.

    BACKGROUND
  • Lundeberg T, Bondesson L, Lundstrom V. Relief of primary dysmenorrhea by transcutaneous electrical nerve stimulation. Acta Obstet Gynecol Scand. 1985;64(6):491-7. doi: 10.3109/00016348509156727.

    PMID: 3904321BACKGROUND
  • Patel F, Dhupkar A. Effect of Kinesiotaping and Pelvic Tilts on Menstrual Symptom Questionnaire and Visual Analogue Scale in Primary Dysmenorrhoea in Females Aged 18-30 Years.

    BACKGROUND
  • Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.

    PMID: 26564807BACKGROUND
  • Roozbahani RE, Najad RM. A comparison of the effect of stretching exercises and kinesio taping on the primary dysmenorrhea of high school girls. J Arak Uni Med Sci. 2015;18(97):1-8.

    BACKGROUND
  • Shahr-Jerdy S, Hosseini RS, Gh ME. Effects of stretching exercises on primary dysmenorrhea in adolescent girls. Biomedical Human Kinetics. 2012;4(1):127-32.

    BACKGROUND
  • Ahmadi Barati A, Farhadi L, Khalily M. Comparison of the Effect of Stretching Exercises and Combination of Massage-Stretching Exercises on Primary Dysmenorrhea of Female Students of Razi University of Kermanshah. Journal of Clinical Research in Paramedical Sciences. 2021;10(1).

    BACKGROUND
  • Arshad S, Qureshi MF, Deeba F, Sarshad S, Shiraz S, Farooq S, et al. To compare the effectiveness of taping technique and hydrotherapy in treatment of primary dysmenorrhea. Inter J Endor Health Sci Res. 2018;6(3):34-42.

    BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Ghulam Fatima, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 2, 2022

Study Start

April 20, 2022

Primary Completion

October 1, 2022

Study Completion

October 19, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations